CVERNE CAD DETECTOR

Computer, Diagnostic, Pre-programmed, Single-function

CHERNE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Cherne Industries, Inc. with the FDA for Cverne Cad Detector.

Pre-market Notification Details

Device IDK852900
510k NumberK852900
Device Name:CVERNE CAD DETECTOR
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant CHERNE INDUSTRIES, INC. 5701 SOUTH COUNTY RD. 18 Minneapolis,  MN  55436
ContactMark W Kroll
CorrespondentMark W Kroll
CHERNE INDUSTRIES, INC. 5701 SOUTH COUNTY RD. 18 Minneapolis,  MN  55436
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-09
Decision Date1985-09-25

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